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Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low Energy Neurofeedback System
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Electroencephalograph (EEG) biofeedback, Electromagnetic stimulation, Neurofeedback, Neurotherapy, Complementary and Alternative Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Diagnosis of fibromyalgia with symptoms for at least 1 year Self-report of having attention/concentration, memory, multi-tasking or other thinking difficulties Able to read and understand English Able to attend treatment sessions weekly and return for planned follow-ups Appropriate balance of average delta (<4 Hertz) EEG waveband and alpha (approximately 4-8 Hertz) EEG waveband amplitude on LENS screening (to be determined by study personnel); Exclusion criteria: Other chronic pain condition of major significance Current chronic viral infection Current other unstable medical condition History of spinal, including neck, surgery Psychological screening indicates psychotic, suicidal, homicidal, and/or substance abusing Use of long-acting opioid medication taken on a continuous 24-hour dosing schedule Current involved in litigation regarding pain condition or seeking disability History of electroconvulsive therapy

Sites / Locations

  • Oregon Health & Science University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 24, 2004
Last Updated
August 16, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00080184
Brief Title
Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
Official Title
Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether a new form of brainwave biofeedback is effective in the treatment of fibromyalgia.
Detailed Description
Fibromyalgia (FM) is a chronic disorder that involves chronic widespread musculoskeletal pain typically accompanied by fatigue, disordered sleep, cognitive complaints, psychological distress, and impairments in functioning. Treatments to date have been only partially effective and typically of modest benefit. Many persons with FM remain persistently dysfunctional and often disabled. This has given greater impetus for patients to seek complementary and alternative medicine (CAM) therapies. In this study, a variant of electroencephalograph (EEG) biofeedback known as Low Energy Neurofeedback System (LENS) will be used to reduce FM symptoms. Participants in this study will be randomly assigned to receive either LENS or placebo for several sessions. The Fibromyalgia Impact Questionnaire will be used to assess participants at the end of the study and at the 3- and 6- month follow-up visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Electroencephalograph (EEG) biofeedback, Electromagnetic stimulation, Neurofeedback, Neurotherapy, Complementary and Alternative Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Low Energy Neurofeedback System

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Diagnosis of fibromyalgia with symptoms for at least 1 year Self-report of having attention/concentration, memory, multi-tasking or other thinking difficulties Able to read and understand English Able to attend treatment sessions weekly and return for planned follow-ups Appropriate balance of average delta (<4 Hertz) EEG waveband and alpha (approximately 4-8 Hertz) EEG waveband amplitude on LENS screening (to be determined by study personnel); Exclusion criteria: Other chronic pain condition of major significance Current chronic viral infection Current other unstable medical condition History of spinal, including neck, surgery Psychological screening indicates psychotic, suicidal, homicidal, and/or substance abusing Use of long-acting opioid medication taken on a continuous 24-hour dosing schedule Current involved in litigation regarding pain condition or seeking disability History of electroconvulsive therapy
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11406805
Citation
Mueller HH, Donaldson CC, Nelson DV, Layman M. Treatment of fibromyalgia incorporating EEG-Driven stimulation: a clinical outcomes study. J Clin Psychol. 2001 Jul;57(7):933-52. doi: 10.1002/jclp.1060.
Results Reference
background
Links:
URL
http://www.myalgia.com
Description
Information regarding chronic widespread musculoskeletal and myofascial pain with clinical, educational, and research information

Learn more about this trial

Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia

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